A Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Anti-Abeta (MABT5102A) in Patients With Alzheimer's Disease

Genentech, Inc.56 enrolled

Overview

This is a Phase I, multicenter, randomized, double-blind, placebo-controlled study that will be conducted in the United States and consists of a single ascending-dose stage followed by a multidose, parallel-treatment stage. This study will be conducted in approximately 50 adult patients between 50-85 years old who have mild to moderate Alzheimer's disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Alzheimer's Disease

Interventions

anti-AbetaDRUG

Intravenous single and multiple doses

placeboDRUG

Intravenous single and multiple doses

Eligibility

Sex: ALLMin age: 50 YearsMax age: 86 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of probable AD according to the NINCDS-ADRDA Criteria * Approved AD treatments (AchE inhibitors+/-memantine) must be stable for ≥ 3 months prior to screening * Other prescription medications must be stable for ≥ 1 month prior to screening Exclusion Criteria: * Female patients with reproductive potential * History or presence of any clinically significant CNS disease * History of treatment with any protein therapeutic targeting Abeta

Outcomes

Primary Outcomes

Safety and tolerability of single and multiple doses of MABT5102A

Time frame: Through study completion or early study discontinuation

Secondary Outcomes

Pharmacokinetics of MABT5102A after single and multiple doses

Time frame: Through study completion or early study discontinuation

Immunogenicity of MABT5102A after single and multiple doses

Time frame: Through study completion or early study discontinuation

Data from ClinicalTrials.gov

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